DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims corresponding to Group I (drawn to the first subassembly with standard rear cap with blocking surface and activation button that moves from first state to second state, allowing rear cap distal movement to free holding arms) in reply filed on August 25, 2026 is acknowledged.
Status of Claims
This action is in response to restriction election filed on August 25, 2026.
Claims 1-15 are cancelled.
Claims 16-18, 20, 23-26 and 29-30 are pending.
Claims 19, 21-22 and 27-28 are withdrawn from consideration.
Applicant has defined the term “distal direction” as the direction pointing away from the dose delivery site and the term “proximal direction” as the direction pointing toward the dose delivery site (see at least page 3, lines 12-24 of Applicant disclosure). Therefore, the proximal and distal end interpretations of the prior art will be applied in accordance with Applicant definition.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-18, 20, 23-26 and 29-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "the position restricting movement of the holding arm" in line 11. There is insufficient antecedent basis for this limitation in the claim. Claim 16 introduces “a blocking position” and “a non-blocking position,” but does not introduce “a position restricting movement of the holding arm.” It is unclear whether “the position restricting movement of the holding arm” is the blocking position or a different position. Claims 17-18, 20, 23-26 and 29-30 depend from claim 16 and are indefinite for the same reason. For purposes of applying prior art, “the position restricting movement of the holding arm” is interpreted as the blocking position recited in claim 16.
Claim 25 recites the limitation "the medicament delivery operation" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 16-18, 20, 23-26 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 8,814,834 (hereinafter, “Sund”) in view of WO Publication No. 2014/159018 (hereinafter, “Fourt”).
Regarding claim 16, Sund discloses a sub-assembly for a medicament delivery device (injector 12 in figs. 1-2) configured to expel medicament from a medicament container (fluid chamber 22 therein that is configured for storing and dispensing a liquid medicament in fig. 2; col. 4, lines 14-16), the sub-assembly comprising:
a housing (housing 14 in figs. 1-2, 5-7) having a proximal end and a distal end (proximal end and distal end of housing 14 in figs. 1-2, 5,7);
a pre-tensioned plunger rod (ram 60 urged toward distal end of injector 12 by compression spring 52; col. 5, lines 38-40) operably arranged to, upon activation, act on the medicament container for expelling a medicament;
a holding sleeve (inner housing 54 in figs. 2, 6) fixedly attached to the housing (inner housing 54 can be attached to the outer housing 14 in fig. 6; col. 5, lines 31-33), the holding sleeve comprising at least one holding arm (latches 55 in figs. 2-3, 6) arranged to lock the plunger rod in its pre-tensioned state (latches 55 extend from the proximal end of the inner housing 54 and can be resiliently biased outwardly; latch protrusions 56 extend inwardly from the free ends of latches 55 and are received in a respective one of recess 58 formed in ram 60 in a blocking association therewith to prevent distal movement of the ram 60 prior to the firing of the device; col. 5, lines 33-38); and
a rear cap (trigger 64 in figs. 2-3, 6) having a blocking surface (latching portion 68 in fig. 6) arranged to prevent the holding arm from releasing the plunger rod from its pre-tensioned state by restricting movement of the holding arm (trigger 64 with latching portion 68 is provided to retain the latches 55 in an inward position, thereby maintaining protrusions 56 in the blocking association in the recesses 58 to hold ram 60 in the proximal position until firing is actuated; col. 6, lines 8-19), and being operatively configured to move distally from a blocking position to a non-blocking position in which the blocking surface is distant from the position restricting movement of the holding arm (trigger 64 with latching portion 68 is provided to retain the latches 55 in an inward position, thereby maintaining protrusions 56 in the blocking association in the recesses 58 to hold ram 60 in the proximal position until firing is actuated; col. 6, lines 8-19).
Sund fails, however, to disclose an activation button having a locking surface, the activation button being operatively arranged to, upon activation, move from a first state in which the locking surface is abutting the rear cap to prevent the movement of the holding arm from releasing the plunger rod, to a second state in which the locking surface is displaced to thereby allow the holding arm to move radially outwards to release the plunger rod.
Fourt teaches an activation button (Fourt: button 21 in figs. 12-13) having a locking surface (Fourt: blocking surface 70 in figs. 12-13; abuts lock member), the activation button being operatively arranged to, upon activation, move from a first state in which the locking surface is abutting the rear cap to prevent the movement of the holding arm from releasing the plunger rod (Fourt: when button 21 is not plunged and arranged as shown in Fig. 1, side face 137 directly abuts arm end face 70 so that lock ring 110 cannot rotate toward arm surface 72; page 10, lines 21-23), to a second state in which the locking surface is displaced to thereby allow the holding arm to move radially outwards to release the plunger rod (Fourt: when button 21 is in the plunged position, arm end face 70 is axially below or clear of side face 137, allowing tab 135 to move into opening 74 as the lock ring 110 rotates; page 10, line 23 – page 11, line 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pull-off safety abutment on the trigger of Sund to a stay-on activation button having a locking surface that abuts the trigger in a first state and is displaced in a second state, as taught by Fourt, in order to require a deliberate button actuation before the guard can drive the trigger off the latches and reduce accidental firing from dose site skin pressure, vibration, or drop while retaining the distal release of the holding arms.
Regarding claim 17, modified Sund discloses the sub-assembly according to claim 16, wherein the rear cap (trigger 64 in figs. 2-3, 6) comprises a locking interacting surface (Fourt: side face 137 in figs. 13-14) arranged to abut the locking surface of the activation button in the first state (Fourt: side face 137 directly abuts arm end 70 so that lock ring 110 cannot rotate toward arm surface 72 when button 21 is not plunged; figs. 13-14; page 10, lines 21-23) to thereby lock the rear cap from moving to its non-blocking position (Fourt: downward biasing force applied by spring 164 on the rotatably fixed plunger element 155, is prevented by the abutting engagement of end face 70 by lock ring side face 137; page 13, line 24 – page 14, line 2).
Regarding claim 18, modified Sund discloses the sub-assembly according to claim 17, wherein the locking interacting surface (Fourt: side face 137 in figs. 13-14) is arranged distant from the locking surface of the activation button (Fourt: blocking surface 70 in figs. 12-13; abuts lock member) in the second state to thereby enable the rear cap (trigger 64 in figs. 2-3, 6) to move to its non-blocking position (Fourt: when button 21 is in the plunged position, arm end face 70 is axially below or clear of side face 137, allowing tab 135 to move into opening 74 as the lock ring 110 rotates; page 10, line 23 – page 11, line 2).
Regarding claim 20, modified Sund discloses the sub-assembly according to claim 16, wherein the blocking surface of the rear cap is arranged to abut the holding arm of the holding sleeve (latching portion 68 of trigger 64 abuts latches 55 of inner housing 54 in figs. 2, 6) in the blocking position (trigger 64 with latching portion 68 is provided to retain the latches 55 in an inward position, thereby maintaining protrusions 56 in the blocking association in the recesses 58 to hold ram 60 in the proximal position until firing is actuated; col. 5, lines 45-49; col. 6, lines 8-12).
Regarding claim 23, modified Sund discloses the sub-assembly according to claim 16, wherein the holding sleeve (inner housing 54 in figs. 2, 6) comprises a base portion (base of inner housing 54 from which latches 55 extend to form latch protrusions in fig. 6) from which the holding arm distally extends (latches 55 in figs. 2-3, 6), and wherein the holding arm is flexibly arranged relative to the base portion (latches 55 extend from the proximal end of the inner housing 54 and can be resiliently biased outwardly; latch protrusions 56 extend inwardly from the free ends of latches 55 and are received in a respective one of recess 58 formed in ram 60; col. 5, lines 33-38).
Regarding claim 24, modified Sund discloses the sub-assembly according to claim 23, wherein the holding arm is arranged to move from an unflexed state in which the plunger rod is locked in its pre-tensioned state (latches 55 extend from the proximal end of the inner housing 54 and can be resiliently biased outwardly; latch protrusions 56 extend inwardly from the free ends of latches 55 and are received in a respective one of recess 58 formed in ram 60 in a blocking association therewith to prevent distal movement of the ram 60 prior to the firing of the device; col. 5, lines 33-38) to a flexed state in which the plunger rod is released when the rear cap is arranged in its non-blocking position (latch protrusions 56 to move radially outwardly from the recess 58 and therefore from the blocking association; col. 6, lines 16-18) and the activation button is brought to its second state (Fourt: when button 21 is in the plunged position, arm end face 70 is axially below or clear of side face 137, allowing tab 135 to move into opening 74 as the lock ring 110 rotates; page 10, line 23 – page 11, line 2).
Regarding claim 25, modified Sund discloses the sub-assembly according to claim 16, further comprising a delivery member cover (needle guard 66 in fig. 2) arranged in the housing and extending proximally from the proximal end of the housing (injector can further include a guard extending distally of the housing that is retractable with respect to the housing from a protecting position to an actuating position; col. 2, lines 60-63; claim 1), the delivery member cover being configured to, during the medicament delivery operation, move linearly relative to the housing from a protracted position to a retracted position in which the delivery member cover is received further in the housing (needle guard 66 is moveable with respect to outer housing 14 and is retractable, preferably into the outer housing 14, in a proximal direction to an injecting position; col. 5, lines 59-67).
Regarding claim 26, modified Sund discloses the sub-assembly according to claim 25, wherein the delivery member cover (needle guard 66 in fig. 2) comprises a distal end portion (proximal end of needle guard 66) having a pushing surface (surface of needle guard 66 associated with trigger 64) arranged to abut the rear cap (trigger 64 in figs. 2-3, 6) when the delivery member cover is moved to its retracted position to thereby move the rear cap to its non-blocking position (needle guard 66 is associated with the trigger 64 such that when the guard 66 is displaced proximally it slides the trigger 64 also in a proximal direction to release protrusions 56 from the recesses 58; col. 6, lines 5-18).
Regarding claim 29, modified Sund discloses the sub-assembly according to claim 16, further comprising a drive spring biasing (compression spring 52 in figs. 2, 6) the plunger rod towards the proximal end of the housing (ram 60 urged toward distal end of injector 12 by compression spring 52; col. 5, lines 38-40).
Regarding claim 30, modified Sund discloses a medicament delivery device for expelling medicament from a medicament container via a delivery member, the medicament delivery device comprising the sub-assembly according to claim 16 (injector 12 comprising fluid chamber 22 therein that is configured for storing and dispensing a liquid medicament in fig. 2; col. 4, lines 14-16 ).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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